AIDS Vaccine Advocacy Coalition calls for Viread trials to continue (15517)

Although worldwide clinical trials of the anti-HIV drug Viread are drawing criticism from AIDS activists, the AIDS Vaccine Advocacy Coalition on Thursday issued a report that calls for the studies to continue, as the drug is still a possible way to prevent HIV infections. The report, titled "Will a Pill a Day Prevent HIV? Anticipating the Results of the Tenofovir PREP Trials," examines the issues and ethical concerns raised by some activists, particularly whether sex workers and injection-drug users in developing countries participating in the trials are being adequately counseled on safer sex, and whether those who become infected during the study should be given free lifetime supplies of antiretroviral drugs. AVAC says these issues can be adequately addressed by trial organizers and funders, and that the studies should continue with more concerted coordination and advance planning to accelerate data evaluation.

"The concerns raised about the trials are serious, and there is a need for thorough and unbiased investigation," said Mitchell Warren, AVAC executive director, in a press statement. "But all of the concerns raised are solvable. AVAC calls on researchers, communities, and advocates to work together to ensure that ethical concerns are addressed, solutions are found, and the trials go forward."

The studies, under way among sexually active gay men in the United States, female sex workers in Africa, and injection-drug users in Thailand, aim to determine whether daily doses of Viread are effective in preventing HIV infections that are transmitted through sexual contact or needle sharing. The AVAC report says that the World Health Organization, the Joint United Nations Programme on HIV/AIDS, the trial sponsors, and other organizations should work together to ensure that research and trials are coordinated and progress in an accelerated fashion--and that additional research is carried out in an expedited fashion--to ensure that it is known as soon as possible if Viread is a safe and effective HIV prevention intervention.

"We need as many HIV prevention tools as possible, so research on vaccines, microbicides, and other potential interventions must also be accelerated whether or not Viread proves appropriate for preexposure prophylaxis," Warren said.

The AVAC report is available online at www.avac.org and in print by sending a request via e-mail to avac@avac.org.